The Effectiveness of Bioenergy Economy Training Protocols on Quality of Life, Sense of Coherence and Depression Syndromes in Patients with Asthma Problem
The effectiveness of bioenergy economy training protocols on quality of life, sense of coherence and depression syndromes in patients with asthma Problem
Improve daily function of asthma patients' life physically, mentally and energy level by reducing depressive symptoms, increasing quality of life and increasing their sense of coherence.
Design
A quasi-experimental type including pre-test and post-test design by forming two groups of subjects and controls. The target statistical population is patients with asthma. Referring to hospital and asthma clinic after interaction and agreement of the clinic and hospital management,d targeted sampling method among them 40 Individuals are selected as statistical samples and are randomly divided into experimental and control groups. Each of the experimental and control groups will be measured twice, first by performing a pre-test and then by performing a post-test, and then the data will be analyzed.
Settings and conduct
By referring to the hospital lung clinic and asthma clinic after interaction and agreement of the clinic and hospital management, among all clients with asthma diagnosis and selected by available and targeted sampling method among them 40 Individuals are selected as statistical samples
Participants/Inclusion and exclusion criteria
Having any of the 3 degrees of severe, moderate or mild asthma whose severity is known
high school degree or higher
Ability to do daily exercises & assignments, fill out a questionnaire, use auditory and visual tools
Intervention groups
1- Experimental group: Online implementation of the 40 day bioenergy economy training protocol & sending audio/video files to perform homework.
2- Control group : Sending the protocol brochure at the end of the research.
Main outcome variables
Depression, Quality of Life, Sense of Coherence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220106053642N1
Registration date:2022-01-25, 1400/11/05
Registration timing:prospective
Last update:2022-01-25, 1400/11/05
Update count:0
Registration date
2022-01-25, 1400/11/05
Registrant information
Name
Nazila Banihashemi
Name of organization / entity
Islamic Azad University Emirates Branch
Country
Iran (Islamic Republic of)
Phone
+98 21 8601 4874
Email address
banihashemy@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-30, 1400/11/10
Expected recruitment end date
2022-05-31, 1401/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Bioenergy Economy Training Protocols on Quality of Life, Sense of Coherence and Depression Syndromes in Patients with Asthma Problem
Public title
The Effectiveness of Bioenergy Economy Training Protocols on Quality of Life, Sense of Coherence and Depression Syndromes in Patients with Asthma Problem
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Severe, Moderate , Mild Asthma
High school Graduated
Ability of Daily assignment & Exercise accomplish
Ability of Questionnaire fulfillment
Ability of audio & visual instrument
Exclusion criteria:
Any Physical or mental illness with requirement of intensive care which disrupts daily functions
Disability of Accomplish Daily assignment & Exercise
Age
From 20 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
From the target statistical population of lung clinics in Tehran, one clinic was selected by available and purposeful sampling method and from 150 clients after screening based on standard deviation of 40 male and female aged 20-55 years as statistical samples in which each member has an equal and independent chance of membership. To determine the test and control groups by simple randomization method with individual unit of measurement using table of random numbers, after assigning a two-digit code to individuals from 01 to 40, a 40 number table will be prepared and a start point will be selected, then proceeding in a column recording the first two-digit number less than 40 will be recorded as the first sample and continue up to 20 samples ignoring digits above 40 . the rest of numbers will be considered as control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Islamic Azad University- Ahvaz Branch
Street address
Office of Industry and Community Relations, 2nd fl. Office Building, Ahvaz Branch, Islamic Azad University, Farhang Shahr, Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۴۹۳۷۳۳۳
Approval date
2021-10-04, 1400/07/12
Ethics committee reference number
IR.IAU.AHVAZ.REC.1400.152
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
Depression score in Beck Depression Inventory
Timepoint
before starting intervention & end of that after 40 days
Method of measurement
Beck Depression Inventory
2
Description
, quality of life score in 36-item questionnaire
Timepoint
before starting intervention & end of that after 40 days
Method of measurement
, quality of life score in 36-item questionnaire
3
Description
SoC score in Antonovsky Coherence Questionnaire
Timepoint
before starting intervention & end of that after 40 days
Method of measurement
Antonovsky SoC questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group will receive a virtual training protocol (due to Covid 19) based on a schedule of 40 days (16 sessions including 4 parts each 4-classes) online and receive ofline 32 video files of approximately 13 minutes (at the end of each class and at the end of each part). And performing the exercises & assignments at the specific times and sending them back to the researcher during the course (every other day). In the bioenergy economy protocol besides theoretical discussions which will increase trainees' knowledge and stimulate their cognitive elements, light and short physical exercises with relaxation techniques(muscle economy, gaining the most by the least effort), body awareness, homogeneity, conscious attention guidance and changing life narratives will be taught. By strengthening the foundations of cognition and using a systemic approach, without entering into the complexities of the mind, by organizing the mind and reprocessing the energy body, the patient achieves a better organization of emotions and a better understanding of personal, interpersonal, and intrapersonal communication.
Category
Rehabilitation
2
Description
Control group: Receiving brochure at the end of the 40 day course
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Jahad Medical Science of Tehran
Full name of responsible person
Nazila Banihashemi
Street address
Abureihan
City
Tehran
Province
Tehran
Postal code
1315617391
Phone
+98 21 6695 3309
Email
banihashemy@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ashkan Ghafuri
Street address
Office of Industry and Community Relations, 2nd fl., Office building, Islamic Azad University, Ahvaz Branch, Farhang Shahr, Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۴۹-۳۷۳۳۳
Phone
+98 61 3334 8361
Email
info@iauahvaz.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nazila Banihashemi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No.50, 34th st., Gisha
City
Tehran
Province
Tehran
Postal code
1448953359
Phone
+98 21 8601 4874
Email
banihashemy@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nazila Banihashemi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 17, No. 50, 34th st. , Gisha
City
Tehran
Province
Tehran
Postal code
1448953359
Phone
+98 21 8601 4874
Email
banihashemy@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nazila Banihashemy
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 17, No. 50, 34th st..Gisha
City
Tehran
Province
Tehran
Postal code
1448953359
Phone
+98 21 8601 4874
Email
banihashemy@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Research Results & Statistical Details without mentioning to the participants
When the data will become available and for how long
1 Year after Publish
To whom data/document is available
Researchers in Research Centers and Industrial
Under which criteria data/document could be used
Researchers in Research Centers and Industrial
From where data/document is obtainable
Nazila Banihashemy; banihashemy@gmail.com
Dr. Farzad Goli; dr.fgoli@yahoo.com
What processes are involved for a request to access data/document